Accuracy Study of Robot-assisted Screw Insertion in Spinal Surgery

NCT04040868 | Unknown

• 1 other identifier: JST-201903
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators present the design of a randomized trial to compare the accuracy and safety of screw insertion using the robot-assisted technique versus the conventional fluoroscopy-assisted technique in spine surgery at multicenter. The accuracy and safety of screw insertion are measured by deviation of guide pin placement position, deviation of screw placement position, and intraoperative or postoperative complications. Secondary outcome parameters such as radiation exposure, postoperative recovery, duration of surgery, length of hospital stay and economic appraisal were also evaluated and compared between treatment groups.

Conditions

the Robot-assisted Technique

Outcome Measures

Primary Outcomes (6)

• Deviation of guide pin placement position

  After completing guide pin placement preparation, do the C arm scan, obtain 3-D scanning image, plan on the image, position by the robot, finish the needle placement and obtain 3-D scanning image again. Fusion two groups of the image, measure the distance between the entry and exit points of the guide pin and the surgical planning, calculate the insertion deviation, and evaluate the insertion accuracy of the guide pin. Insertion deviation = (Input offset distance + Output offset distance) / 2, the unit is mm. If more than one guide pin is needed for the operation, the deviation of the insertion shall be calculated separately and the average shall be taken.

  during operation

• Time of guide pin adjustion

  After the guide pin is placed, when the position deviation needs to be adjusted, the time consumed by adjusting the guide pin.

  during operation

• Deviation of screw placement position

  Postoperative screw placement position deviation was measured. The position of spinal screws was evaluated by postoperative imaging. Standard for classification of spinal screw placement : Excellent：The screw was completely in the pedicle and did not penetrate the cortex. Good: The screw cortical perforation \< 2mm, or less than 50% of the screw diameter. Bad： The screw cortical perforation \> 2mm, or more than 50% of the screw diameter.

  during operation

• Time of screw adjustion

  After the screw is placed, when the position deviation needs to be adjusted, the time consumed by adjusting the screw.

  during operation

• Intraoperative Complications

  Intraoperative complications, including but not limited to: positioning complications (blindness, nerve injury, skin breakdown), acute spinal cord injury, vascular Injury(vertebral injury, aorto-iliac injury), cardiovascular events, pulmonary complications, acute kidney injury.

  After operation up to 4 weeks

• Postoperative Complications

  Postoperative complications，including but not limited to: cardiovascular events, pulmonary complications, acute kidney injury, ileus, coagulopathy and wound infection. The time was within 1 year after the operation.

  The time was within 1 year after the operation.

Secondary Outcomes (24)

• Duration of surgery

  during operation

• Radiation exposure

  during operation

• Visual analogue scale (VAS) score 24 hours before surgery

  24 hours before surgery

• Visual analogue scale (VAS) score 24 hours after surgery

  24 hours after surgery

• Visual analogue scale (VAS) score 3 months after surgery

  3 months after surgery

Study Arms (2)

robot-assisted technique

OTHER

Device: the TiRobot system

conventional fluoroscopy-assisted technique

OTHER

Device: Freehand

Interventions

the TiRobot system DEVICE

The TiRobot system (TINAVI Medical Technologies Co. Ltd.) is a multi-indication orthopedic surgical robot that can be used in spinal, pelvic, and limb surgeries performed via an open or a minimally invasive approach

robot-assisted technique

Freehand DEVICE

conventional fluoroscopy-assisted

conventional fluoroscopy-assisted technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or above, gender not limited;
• patients eligible for surgery;
• the patient signed the informed consent and agreed to participate in this study.

You may not qualify if:

• patients with severe osteoporosis;
• patients with old fractures;
• patients with developmental deformity of the vertebral body with screw placement;
• patients complicated with severe systemic diseases;
• patients with coagulation dysfunction;
• patients deemed unsuitable for the test by the clinical institution.

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Study Sites (1)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

RECRUITING

Related Publications (1)

• Fan M, Fang Y, Zhang Q, Zhao J, Liu B, Tian W. A prospective cohort study of the accuracy and safety of robot-assisted minimally invasive spinal surgery. BMC Surg. 2022 Feb 11;22(1):47. doi: 10.1186/s12893-022-01503-4.

  PMID: 35148734 DERIVED

Central Study Contacts

Wei Tian, MD. PHD

CONTACT

86-13901174297; tianwei_victor@163.com

Mingxing Fan, MD. PHD

CONTACT

86-13683360600; van0208@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Beijing Jishuitan Hospital

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: August 1, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)